The present invention relates generally to breathing devices and, more particularly, to a uniquely-configured retainer clip that is specifically adapted to anchor a tubing member to a patient. The retainer clip assists in maintaining sealing engagement of a user interface (e.g., nasal mask, nasal cannula) to the patient by directly affixing the tubing member to the patient such as to the patient's cheek. The retainer clip assists in preventing dislodgement of the user interface as may occur in infants and neonates whose frequent head movements can compromise the sealing of the user interface or whose frequent handling by others such as during feeding can cause dislodgement of the user interface.
The use of breathing devices upon respiratory-impaired patients is well known. Generally, such apparatuses assist in patient breathing by allowing proper exchange of inhaled and exhaled gas and/or by delivering oxygen and/or medication to the patient. In one form of respiratory therapy, continuous positive airway pressure (CPAP) devices are specifically adapted to provide pressurized gasses to a patient's lungs while allowing spontaneous breathing by the patient.
CPAP devices typically include a gas source such as a blower unit which is connected to the user interface by a tubing member such as a gas supply tube. The user interface can be configured for invasive or non-invasive CPAP therapy wherein gas is ideally delivered to the patient at a constant and stable pressure. For invasive CPAP therapy, gas is delivered to the patient via a tracheal tube. For non-invasive CPAP therapy, gas is delivered to the patient's mouth and/or nose such as via a nose piece member or a face mask on the patient's head. The nose piece member may be integrally formed with the user interface or it may be a separate component.
Nose piece members (i.e., nasal masks, nasal pillows or plugs) are typically fabricated of a soft, elastic polymeric material which provides a comfortable surface to bear against the patient's skin. For nose piece members used in CPAP therapy, pressurized gas is directed into the patient's nostrils through a pair of nostril-engaging stems which are typically configured to anatomically conform to the interior of the patient's nostrils.
The ability to supply pressurized gas to the airways of a patient on a constant basis and at a stable pressure is critical in the effectiveness of CPAP ventilation. The application of constant CPAP therapy is especially important in treating certain respiratory complications in neonates such as respiratory distress syndrome (RDS). The proper application of CPAP ventilation is proven to be effective in developing and restoring respiratory capacity in neonates and infants.
Unfortunately, although prior art CPAP devices are generally effective in delivering respiratory therapy to a variety of patients including infants, such breathing devices possess certain deficiencies which detract from their overall effectiveness. These deficiencies are associated with user interfaces wherein CPAP therapy is delivered via mouth and/or nasal-based devices such as nasal masks, nasal prongs or nasal cannulae. For example, some of the prior art nasal masks and nasal prongs are secured to the patient using a system of straps which wrap around the patient's head in order to hold the user interface in position against the patient's nose such that a proper seal is maintained at the user interface.
Unfortunately, the system of straps is typically uncomfortable when worn for extended periods of time. If adjusted too tightly, the straps create excessive pressure at the user interface against the patient's face which is particularly problematic if the user interface is provided as a pair of nasal prongs. More particularly, if the straps are adjusted too tightly around the patient's head, the nasal prongs may be forced upwardly into the patient's nose which can result in irritation of the tender mucus tissue lining the patient's nostrils. In addition, overly-tightened straps can result in general patient discomfort as well as other health complications. The above-described scenario associated with strap over-tightening is especially problematic for neonates and infants who are incapable of communicating to a caretaker the nature of their discomfort.
The administration of CPAP therapy via nasal cannulae is considered by some to be a more comfortable alternative to nasal masks or mouth-based user interface devices. Furthermore, the use of nasal cannulae in CPAP therapy is better tolerated by neonates as compared to nasal masks. However, proper fitment and positioning of nasal cannulae on the patient is imperative because unlike invasive CPAP user interfaces (i.e., nasal masks, nasal prongs, face masks) which include a pressure tube for monitoring pressure at the patient, pressure delivered via nasal cannulae is typically preset and regulated at the pressure source such that excessively low or high pressure at the patient airway is undetectable.
As is known in the art, dangerously high pressures subject the patient to the risk of injury including damage to the lungs and other organs and may lead to additional respiratory complications. On the other hand, excessively low pressure at the patient can drastically reduce the effectiveness of CPAP therapy, especially in the case of neonates and infants wherein the ability to restore and develop full respiratory capability is predicated on the delivery of gas at an appropriate pressure on a constant basis.
Low pressure at the user interface can result from leaks generated between the user interface and the patient's nose and/or mouth. Such leaks may be a result of improper positioning of the user interface on the patient. However, leaks can be generated at the user interface as a result of normal patient movement. Particularly for infants who make frequent jerking and shaking movements as part of their normal physical development, securement of the user interface to the infant's nose and/or mouth is critical in facilitating the delivery of respiratory therapy on a continuous basis at the appropriate pressure.
As can be seen, there exists a need in the art for a user interface for ventilation systems such as CPAP devices which includes a means for maintaining the position of the user interface relative to the patient's nose and/or mouth. Furthermore, there exists a need in the art for a user interface that is comfortable to wear during extended periods of time such that respiratory therapy can be provided to the patient on a continuous and uninterrupted basis despite normal patient movements. Additionally, there exists a need in the art for a fixation mechanism for supporting a tubing member that may be connected to the user interface. Finally, there exists a need in the art for a fixation mechanism which is capable of maintaining the position of the user interface and which is of simple construction, low cost and which is conveniently installable.